Endo-Model Modular Knee Prosthesis System 15-8521/10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04026575381753), received between Jul 21, 2023 and May 16, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REPRESENTATIVE (B)(6) REPORTED THAT IN 2 CASES FOR REVISIONS TO CONDYLAR REPLACEMENT COMPONENTS, ONE OF THE CONDYLAR CAPS WAS FOUND FLOATING IN THE JOINT SPACE UPON OPENING THE KNEE CAPSULE. THE CASE WAS A REVISION OF THE KNEE FOR INFECTION WHERE THE SURGEON WAS EITHER REPLACING OR REMOVING PARTS AND WASHING OUT THE KNEE. THE CAP WAS NOT REMOVED BY THE SURGEON BUT INSTEAD HAD COME DISLODGED PRIOR TO THE SURGERY. IN THIS CASE, THE FEMORAL COMPONENT REMAINED IMPLANTED WITHOUT THE CAP AND ONLY THE POLY TIBIAL PLATEAU WAS SWAPPED. NO DELAY IN THE PROCEDURE. [CUSTOMER].

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 22034673 ↗
• MalfunctionMay 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REPRESENTATIVE (B)(6) REPORTED THAT IN 2 CASES FOR REVISIONS TO CONDYLAR REPLACEMENT COMPONENTS, ONE OF THE CONDYLAR CAPS WAS FOUND FLOATING IN THE JOINT SPACE UPON OPENING THE KNEE CAPSULE. THE CASE WAS A REVISION OF THE KNEE FOR INFECTION WHERE THE SURGEON WAS EITHER REPLACING OR REMOVING PARTS AND WASHING OUT THE KNEE. THE CAP WAS NOT REMOVED BY THE SURGEON BUT INSTEAD HAD COME DISLODGED PRIOR TO THE SURGERY. IN THIS CASE, THE ENTIRE IMPLANT WAS REMOVED AND REPLACED WITH A FUSION NAIL. THERE WAS NO DELAY IN THE PROCEDURE. [CUSTOMER].

  Patient problems: Unspecified Infection

  MAUDE report 22034672 ↗
• InjuryMay 1, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REPORTED FROM A CASE OF A REVISION TO A CONDYLAR REPLACEMENT COMPONENT, ONE OF THE CONDYLAR CAPS WAS FOUND FLOATING IN THE JOINT SPACE UPON OPENING THE KNEE CAPSULE. THE CASE WAS A REVISION OF THE KNEE FOR INFECTION WHERE THE SURGEON WAS EITHER REPLACING OR REMOVING PARTS AND WASHING OUT THE KNEE. THE FEMORAL COMPONENT REMAINED IMPLANTED WITHOUT THE CAP AND ONLY THE POLY TIBIAL PLATEAU WAS SWAPPED OUT DURING THE REVISION.

  Patient problems: Joint Laxity

  MAUDE report 21942171 ↗
• MalfunctionJul 21, 2023Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging; Delivered as Unsterile Product; Tear, Rip or Hole in Device Packaging

  DURING SURGERY LAST WEEK, THE SURGEON WANTED TO USE IMPLANT 15-8521/10 LOT 200113/1159 07/25 BUT WAS UNPLEASANTLY SURPRISED TO FIND THAT THE STERILE BAG HAD BEEN PUNCTURED. THE CARDBOARD PACKAGING OF THE IMPLANT WAS NOT DAMAGED.

  Patient problems: Insufficient Information

  MAUDE report 17369330 ↗